510(k) K972287 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
DADE TRU-LIQUID BILIRUBIN CONTROL
| Applicant | Dade Intl., Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jul 7, 1997 |
| Received | Jun 19, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972287
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.